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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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New safety signal for psoriasis associated with Angiotensin receptor blockers: qualitative and quantitative analysis using Pharmacovigilance tools

Author: HARDIK BHATT, TUSHAR DESAI
Abstract: Study objective: To qualitatively and quantitatively analyze the association between use of Angiotensin receptor blocker class of drugs and psoriasis from Canadian Adverse Reaction database and published literature. Research Design and method: Reports of psoriasis associated with use of Angiotensin receptor blocker class of drug were retrieved from public version of Canadian Adverse Reaction (CADRMP) database between January 2000 and December 2016 and analyzed for quantitative signal detection by data mining algorithms mainly reporting odds ratio (ROR), proportional reporting ratios (PRR) and 95% confidence interval (CI) of PRR. Also for qualitative analysis, reports for psoriasis associated with ARBs were obtained from literature regulatory agency reports for period from 2000 to 2016. Results: Based on CADRMP data from January 2000 and December 2016, total 9 reports were obtained for psoriasis associated with use of ARBs. Thus, as per our results obtained; value of PRR, ROR and 95% CI for PRR were found to be 17.5, 17.7 and 4.4, respectively indicating significant new signal for aggravated psoriasis associated with ARBs use, however these signals were stronger for Valsartan than other ARBs. Conclusions: Thus public version of CADRMP database as well as literatures and regulatory agency report represents an important source to detect signals of psoriasis. In particular, our present study generated significant new signals for psoriasis among ARBs for which further investigations and active surveillance are warranted. These signals should be considered in evaluating the benefit-risk profile of these drugs.
Keyword: Angiotensin receptor blocker, Signal detection, Adverse drug events, Psoriasis
DOI: https://doi.org/10.31838/ijpr/2020.12.04.068
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